RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY

K051671 · Radiancy (Israel) , Ltd. · GEX · Sep 2, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051671
• Device Name: RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY
• Applicant: Radiancy (Israel) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.

Device Story

SkinStation provides phototherapeutic light for dermatological treatment; specifically hair removal. Device utilizes modified light unit assembly (LUA) to deliver pulsed light energy to skin surface. Operated by clinicians in professional settings. Output consists of controlled light pulses targeting hair follicles. Clinical decision-making supported by device's ability to treat broader range of Fitzpatrick skin types (I-VI). Benefits include effective hair removal for patients with darker skin tones.

Clinical Evidence

Clinical data provided demonstrating efficacy and safety for hair removal in Fitzpatrick skin types V-VI. Results indicate successful hair removal with only minor side effects.

Technological Characteristics

Pulsed light system; modified light unit assembly (LUA) for hair removal; Fitzpatrick skin types I-VI compatibility.

Indications for Use

Indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Radiancy SkinStation Photoepilation Systems
• AesThera Corporation, Model AIP
• Medical Bio Care Sweden AB., ProLite
• Palomar Medical Technologies, Inc., StarLux

Submission Summary (Full Text)

{0}------------------------------------------------

### 510(k) SUMMARY

# KOSI671

## Radiancy (Israel) Ltd.'s Radiancy SkinStation® Photoepilation System with Modified Light Unit Assembly for Hair Removal

## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| Manufacturer: | Radiancy (Israel) Ltd.<br>9 Gan Rave Street<br>Industrial Park<br>Yavne<br>Israel |
|--------------------------|-----------------------------------------------------------------------------------|
| | |
| Telephone:<br>Facsimile: | [phone]<br>[phone] |

| Contact Person: | Jonathan S. Kahan, Esq.<br>Regulatory Counsel<br>Hogan & Hartson L.L.P.<br>555 Thirteenth Street, N.W.<br>Washington, D.C. 20004-1109<br>Telephone: [phone]<br>Facsimile: [phone]<br>Email: [e-mail] |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | June 22, 2005 |

### Name of Device and Name/Address of Sponsor

| Trade/Proprietary Name: | Radiancy SkinStation with Modified LUA |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Pulsed Light System and Light Unit Assembly |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology (21 C.F.R. § 878.4810) |

| Manufacturing Facility: | Radiancy (Israel) Ltd. |
|-------------------------|------------------------|
| | 9 Gan Rave Street |
| | Industrial Park |
| | Yavne, Israel |

| Establishment | |
|------------------------|---------|
| Registration Number: | 9616256 |
| Owner/operator number: | 9040071 |

{1}------------------------------------------------

#### Predicate Devices

Radiancy SkinStation Photoepilation Systems

AesThera Corporation, Model AIP

Medical Bio Care Sweden AB., ProLite

Palomar Medical Technologies, Inc., StarLux

#### Intended Use / Indications for Use

The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.

#### Technological Characteristics

The Skin Station that is the subject of this 510(k) notice is the exact same device as the cleared Skin Station except for the addition of a light unit assembly specifically for hair removal in Fitzpatrick Skin Types V and VI.

#### Substantial Equivalence

The Radiancy SkinStation, as modified, has the same intended use and very similar indications for use, principles of operation and technological characteristics as the cleared Radiancy SkinStation, and with the AesThera Corporation Model AIP, Medical Bio Care Sweden AB. ProLite, and the Palomar Medical Technologies, Inc., StarLux. The minor difference between the Radiancy SkinStation and the predicates do not raise new issues of safety and effectiveness. Clinical data demonstrates that the Radiancy SkinStation removes unwanted body and/or facial hair in adults with Fitzpatrick skin types V-VI with only minor side effects. Thus, the Radiancy SkinStation are substantially equivalent.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and entwined snakes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

Radiancy (Israel) Ltd. c/o Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street Washington, D.C. 20004-1109

Re: K051671

Trade/Device Name: Radiancy Skin Station with Modified Light Unit Assembly Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 22, 2005 Received: June 22, 2005

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave ro rowed your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to Has) 2018-11-19, 2018 11:15 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

#### Page 2- Mr. Jonathan S. Kahan, Esq.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manisang of substantial equivalence of your device to a legally premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acrive int 3 %. [phone]. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Barbara Buchnd
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

#### Page 1 of 1

### Indications for Use Form

| 510(k) Number (if known): | K051671 |
|---------------------------|--------------------------------------------------------|
| Device Name: | Radiancy SkinStation with Modified Light Unit Assembly |
| Indications for Use: | |

The SkinStation is intended to provide phototherapeutic light to the body and is generally indicated to treat dermatological conditions. The SkinStation is specifically indicated for removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I-VI.

Prescription Use __X_

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 C F.R. 801.109)

## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Aubare Preelunds for mXm
Division Sign Off

peral. Restorative, Division of Ge and Neurological De

**510(k) Number** K051671

\\\PH - 69039/0002 - 19155 v1